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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST. JUDE MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR
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ST. JUDE MEDICAL BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH; TROCAR Back to Search Results
Model Number G407209
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Stroke/CVA (1770)
Event Date 09/09/2019
Event Type  Injury  
Manufacturer Narrative
An event of a stroke was reported.The results of the investigation are inconclusive since the device was not returned for analysis. additionally, the device history record was unable to be reviewed as a lot number was not provided. based on the information received, the cause of the reported stroke could not be conclusively determined.
 
Event Description
Related manufacturing ref: 3005334138-2019-00551, 2182269-2019-00172, 2030404-2019-00102, 3005334138-2019-00552, 2182269-2019-00173.Following a left atrial pulmonary vein isolation procedure, a stroke occurred.No complications or patient symptoms were observed during the procedure.The patient is recovering.There were no performance issues with any abbott device.
 
Manufacturer Narrative
An event of a stroke was reported.The results of the investigation are inconclusive since the device was not returned for analysis. additionally, no lot number was provided so a review of the device history record (dhr) was not possible. based on the information received, the cause of the reported stroke could not be conclusively determined.
 
Event Description
Following a left atrial pulmonary vein isolation procedure, a stroke occurred.No complications or patient symptoms were observed during the procedure.Anticoagulation was required for the stroke.The patient is still in rehabilitation and is regaining speech as of (b)(6).There were no performance issues with any abbott device.
 
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Brand Name
BRK-1¿ XS TRANSSEPTAL NEEDLE, 71 CM LENGTH
Type of Device
TROCAR
Manufacturer (Section D)
ST. JUDE MEDICAL
parque industrial, zona franca coyol s.a.
edificio #44b, calle 0, avenida 2, coyol
alajuela, costa rica 1897- 4050
CS  1897-4050
MDR Report Key9136418
MDR Text Key160844531
Report Number3008452825-2019-00491
Device Sequence Number1
Product Code DRC
Combination Product (y/n)N
PMA/PMN Number
K122587
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/30/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberG407209
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ADVISOR¿ FL, CIRCULAR MAPPING CATHETER; AGILIS¿ NXT STEERABLE INTRODUCER; INQUIRY¿ STEERABLE DIAGNOSTIC CATHETER; LIVEWIRE¿ DIAGNOSTIC CATHETER; TACTICATH¿ ABLATION CATHETER, SENSOR ENABLED¿
Patient Outcome(s) Other;
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